On April 18, 2023 Palleon Pharmaceuticals, a clinical-stage company pioneering glyco-immunology drug development to treat cancer and inflammatory diseases, reported the initial Phase 1 results from the GLIMMER-01 trial of its lead EAGLE oncology platform program, E-602, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023 in Orlando, Florida (Press release, Palleon Pharmaceuticals, APR 18, 2023, View Source [SID1234630286]).
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The study demonstrated proof of mechanism for E-602, a first-in-class glyco-immune checkpoint inhibitor, including dose dependent desialylation and dose dependent immune system activation. Additionally, E-602 was found to be well tolerated across the entire dose range evaluated with no dose limiting toxicities. Having met pre-specified gating criteria based on safety and pharmacodynamic activity, Palleon announced plans to proceed with Phase 2 evaluation.
"E-602 represents a truly novel immuno-oncology candidate that builds on the promise of glycobiology, a field of study that offers unprecedented opportunities for drug development in cancer and other diseases," said David Feltquate, M.D., Ph.D., Chief Medical Officer of Palleon Pharmaceuticals. "Establishing proof of mechanism for this approach provides the validation necessary to initiate Phase 2 evaluation and take next steps towards our team’s shared goal of offering new options for patients in need."
"It is exciting to see the first clinical results generated from Palleon’s EAGLE glyco-immunology drug development platform," said Carolyn Bertozzi, Ph.D., Palleon Scientific Co-Founder and 2022 Nobel laureate. "Palleon is advancing an entirely new axis of immune modulation, defined by the interaction between sialoglycans and their receptors, which may benefit patients who do not respond to current medications."
In the initial results from the GLIMMER-01 trial presented by lead investigator, Jason Luke, M.D., of UPMC Hillman Cancer Center, 40 patients were treated with at least one dose of E-602, the most common tumors treated being colorectal (n=21) and pancreatic (n=10). Doses up to 30 mg/kg were tolerated with no dose-limiting toxicities. Both dose-dependent desialylation and immune system activation, as measured by increases in activated (CD69+) immune cells in circulation and elevation of circulating cytokines and chemokines including IP-10/CXCL10, were observed. Phase 2 studies will evaluate clinical activity of E-602 monotherapy in patients with lung cancer and melanoma.
The presentation can be found in the Palleon Publications section of the Education Hub page of our website.